Pfizer breast cancer drug shows promise
pharmafile | February 4, 2014 | News story | Research and Development, Sales and Marketing | Cancer, Pfizer, breast, femara, letrozole, palbociclib
Pfizer’s experimental breast cancer drug palbociclib has successfully extended progression-free survival in a Phase II trial.
The pill was administered in combination with Novartis’ Femara (letrozole) to post-menopausal women with advanced tumours, and was found to be more effective than letrozole alone.
The new treatment is being heralded as a potential blockbuster, with some analysts predicting peak annual sales of $5 billion, according to Reuters.
Two Phase III trials of the drug are already in progress. One is evaluating it as a first-line treatment for breast cancer in combination with letrozole, and the second is investigating its impact with Astrazeneca’s Faslodex (fulvestrant) on patients who have already undergone endocrine therapy.
Palbociclib received ‘breakthrough therapy’ designation from the US Food and Drug Administration (FDA) last year, speeding up its review process.
Pfizer’s Oncology chief medical officer Mace Rothenberg said: “We are delighted with the final data, which suggest the potential for palbociclib to transform the standard of care for post-menopausal women with ER+ and HER2- advanced breast cancer.
“This is encouraging information for these women, who represent approximately 60% of the advanced breast cancer population.”
Rothenberg added that Pfizer would discuss these results with the FDA “with the goal of bringing a much-needed new medicine to patients” – suggesting the firm may push for early approval based on these Phase II data.
A secondary target of the trial was to improve overall survival, although figures on that outcome are not yet available. More detailed results from the study will be presented at the American Association for Cancer Research’s annual meeting in April.
Oncology has been a key growth area for the Pfizer since it started to lose patents on its record-breaking blockbuster Lipitor (atorvastatin) in 2011.
Treatments such as Xalkori (crizotinib) for lung cancer, Inlyta (axitinib) for renal cell carcinoma and Bosulif (bosutinib) for leukaemia have all received regulatory approval in the last number of years.
Palbociclib is part of a class of drugs called cyclin-dependent kinase (CDK) inhibitors which function by blocking the multiplication of tumour cells. Other firms developing similar treatments include Lilly, Novartis and Bayer.
Breast cancer is the most common type of cancer among women and lead to more than half a million deaths globally in 2011, according to the World Health Organization.
Hugh McCafferty
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